Market Newsdesk

THE WOODLANDS, Texas, June 24, 2021 (GLOBE NEWSWIRE) — ChampionX Corporation (“ChampionX” or the “Company”) (NASDAQ: CHX) announced today that it will release its second quarter 2021 operating results on Wednesday, July 28, 2021, after the market closes. The Company has scheduled a conference call for Thursday, July 29, 2021, at 8:00 a.m. Central Time (9:00 a.m. Eastern Time) to discuss the results.

The call will be available by live webcast on ChampionX’s website at https://investors.championx.com or by dialing in as follows:

Please register for the webcast or dial into the call approximately 15 minutes prior to the scheduled start time.

A replay of the conference call will be available for approximately 30 days on ChampionX’s website or at ChampionXSecondQuarter2021CallReplay. Enter passcode 50190035.

About ChampionX

ChampionX is a global leader in chemistry solutions and highly engineered equipment and technologies that help companies drill for and produce oil and gas safely and efficiently around the world. ChampionX’s products provide efficient functioning throughout the lifecycle of a well with a focus on the production phase of wells. To learn more about ChampionX, visit our website at www.championX.com.

Investor Contact:
Byron Pope – [email protected] – 281-602-0094

Media Contact:
John Breed – [email protected] – 281-403-3751

C
ompany
a
nnouncement – No. 41
/ 202
1

Zealand Pharma
Announces U.S. Commercial Availability
of
ZEGALOGUE
® (dasiglucagon)
i
njection

• Z
  EGALOGUE
  now
  available in both an auto
  –
  injector and prefilled syringe for the treatment of severe hypoglycemia in patients with diabetes age
  d
  6
  years and
  older

• Zealand Pharma
  introduces
  ConnectedCare
  
  ^TM
  
  patient support program
  to facilitate access
  with educational and affordability resources
  for
  people with diabetes and their caregivers

Copenhagen, DK and Boston
,
MA, U.S.
June
24
, 202
1
– Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078) a biotechnology company focused on the discovery, development and commercialization of innovative peptide-based medicines, today announced that ZEGALOGUE^® (dasiglucagon) injection 0.6mg/0.6mL is now commercially available in the U.S. in both an auto-injector and prefilled syringe.

“We are thrilled to announce that ZEGALOGUE is now available to support people with diabetes and their caregivers,” said Frank Sanders, President of U.S. Operations for Zealand Pharma. “One of the most frightening aspects of living with type 1 diabetes is the ever-present worry that an unexpected severe hypoglycemic event could occur at any time. This can be especially worrisome for people who are preparing for travel, the back to school season with a resumption of in-person learning, and other events away from home after a long period of isolation during the pandemic. The commercial availability of ZEGALOGUE brings us one step closer to helping people feel confident and prepared to address the unpredictable nature of severe hypoglycemia.”

“Each minute that passes during a severe hypoglycemic incident increases the risk of additional, and more serious, consequences, which underscores the need for treatments that work quickly and consistently,” said Stuart Weinzimer, MD, a Professor of Pediatric Endocrinology at the Yale School of Medicine. “Rescue therapies are under-prescribed for people with diabetes. It is critical for patients and families to discuss hypoglycemia and available rescue therapies with their clinicians, particularly as students with diabetes return to school. Similar to how other emergency treatments for food allergies are widely available and prescribed, we anticipate that the availability of new products like ZEGALOGUE will increase the awareness and importance of having rescue therapies offered to patients at risk of having very low blood sugar.”  

Zealand is committed to making a positive difference in the lives of patients with diabetes and ensuring that ZEGALOGUE is available to as many people at risk for severe hypoglycemia as possible. 

“We are proud to introduce Zealand Pharma ConnectedCare, a comprehensive patient support program designed to offer affordability resources, reimbursement and educational support to help address the diverse needs of patients and caregivers,” said Mr. Sanders. 

The program includes co-pay support for eligible commercially insured patients who may pay as little as $25 for up to two ZEGALOGUE devices per fill, and the opportunity to receive home prescription delivery.  Information on Zealand Pharma ConnectedCare is available at www.zegalogue.com.

The U.S. Food and Drug Administration (FDA) approved ZEGALOGUE on March 22, 2021 for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.

Severe hypoglycemia is an acute, life-threatening condition resulting from a critical drop in blood glucose levels associated primarily with insulin therapy and is one of the most feared complications of diabetes treatment¹. Children with diabetes on insulin are particularly affected, with 7 out 100 children up to the age of 18 reporting severe hypoglycemia in the previous 6 months². While patients have the ability to monitor and adjust their blood glucose levels to remain in proper glycemic control, it’s not always possible to prevent a severe hypoglycemic event.

INDICATION

ZEGALOGUE (dasiglucagon) injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.

IMPORTANT SAFETY INFORMATION

Contraindications

ZEGALOGUE is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure and in patients with insulinoma because of the risk of hypoglycemia.

Warnings and Precautions

ZEGALOGUE is contraindicated in patients with pheochromocytoma because glucagon products may stimulate the release of catecholamines from the tumor. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

In patients with insulinoma, administration of glucagon products may produce an initial increase in blood glucose; however, ZEGALOGUE administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. ZEGALOGUE is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of ZEGALOGUE, give glucose orally or intravenously.

Allergic reactions have been reported with glucagon products; these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions.

ZEGALOGUE is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for ZEGALOGUE administration to be effective. Patients with these conditions should be treated with glucose.

Adverse Reactions

The most common adverse reactions (≥2%) associated with ZEGALOGUE in adults were nausea, vomiting, headache, diarrhea and injection site pain; in pediatrics: nausea, vomiting, headache and injection site pain.

Drug Interactions

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given ZEGALOGUE. In patients taking indomethacin, ZEGALOGUE may lose its ability to raise blood glucose or may produce hypoglycemia. ZEGALOGUE may increase the anticoagulant effect of warfarin.

Please click

here

to see the full Prescribing Information for Zegalogue.

¹ Strandberg RB, et al. Diabetes Res Clin Pract. 2017:11-19.

² Saydah S et al. Endocrinol Diab Metab. 2019;2:e00057

# # #

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery, development, and commercialization of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s robust pipeline of investigational medicines includes three candidates in late-stage development. Zealand markets V-Go®, a basal-bolus insulin delivery option for people with diabetes, and has received FDA approval for Zegalogue, (dasiglucagon), the first and only glucagon analogue for the treatment severe hypoglycemia in pediatric and adult patients with diabetes aged 6 and above. License collaborations with Boehringer Ingelheim and Alexion Pharmaceuticals create opportunity for more patients to potentially benefit from Zealand-invented peptide investigational agents currently in development.

Zealand was founded in 1998 in Copenhagen, Denmark, and has presence throughout the U.S. that includes key locations in Boston, and Marlborough (MA). For more information about Zealand’s business and activities, please visit http://www.zealandpharma.com.

ZEGALOGUE ® is a registered trademark of Zealand Pharma A/S.

Forward-Looking Statement

This press release contains “forward-looking statements”, as that terms is defined in the Private Securities Litigation Reform Act of 1995, as amended, that provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, the occurrence of adverse safety events; risks of unexpected costs or delays; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; product liability claims; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this press release and are based on information available to Zealand Pharma as of the date of this release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

For further information, please contact:

STMicroelectronics
Cooperates with Arrival to Provide
Leading-Edge
Technolog
ies
for Next-Generation Electric Vehicles

• Arrival’s entire vehicle portfolio, including its Van, Bus, and recently announced Car, will feature ST’s
  technologies
• Collaboration includes products dedicated to processing, power and battery
  management

Geneva, Switzerland; and
London, UK
–
June 24
, 2021 — STMicroelectronics (“ST”) (NYSE: STM), a global semiconductor leader serving customers across the spectrum of electronics applications, announced its collaboration with Arrival (NASDAQ: ARVL), the global technology company creating electric vehicles (EVs) using its unique technologies, to provide leading-edge semiconductor technologies and products for Arrival’s vehicles including automotive microcontrollers and power and battery-management devices.

Arrival has chosen ST as one of its key partners in bringing its connected EVs to market. ST’s technology will provide Arrival’s customers with future-proofed zero-emission commercial vehicles as part of an integrated mobility ecosystem. Arrival has selected ST’s high-performance, secure automotive microcontrollers for their modular ECU platform, as well as other ST technologies including smart-power and battery-management devices for efficient vehicle electrification.

Arrival believes its vehicles represent the next generation of EVs having been developed from the ground up using a radical new method of design and production. This vertically integrated approach using in-house developed hardware, software and robotics enables production in decentralised Microfactories. These Microfactories can be deployed around the world to service demand and supercharge local communities by hiring local talent, utilising local supply chains, and paying local taxes.

Arrival’s entire vehicle portfolio, including its Van, Bus, and recently announced Car, which is being designed in partnership with Uber for ride-hailing, will feature ST’s technologies. Arrival has already secured a commitment to purchase from UPS for up to 10,000 electric vehicles, with the option for 10,000 more, and will see trials of its vehicles starting later this year.

“We have been working with Arrival since their early stages, and we are proud of the journey accomplished together as they head towards production,” said Michael Anfang, Executive Vice President, Sales & Marketing, Europe, Middle East and Africa Region at STMicroelectronics. “ST is a broad-based technology supplier for the mobility industry’s transition to electrified and digitalized platforms. This collaboration with a leading new entrant on the market is a testament to our ability to support various operating models. Arrival’s vehicles using ST technology will be an additional step towards our shared vision of cleaner mobility.”  

“STMicroelectronics are producing some of the best technology on the market today. At Arrival, choosing the most advanced technologies for our vehicles is crucial to extending the life of our products, improving their value whilst making them even more sustainable by extending their usable life,” said Sergey Malygin, EVP of Technology at Arrival.

About STMicroelectronics

At ST, we are 46,000 creators and makers of semiconductor technologies mastering the semiconductor supply chain with state-of-the-art manufacturing facilities. An independent device manufacturer, we work with more than 100,000 customers and thousands of partners to design and build products, solutions, and ecosystems that address their challenges and opportunities, and the need to support a more sustainable world. Our technologies enable smarter mobility, more efficient power and energy management, and the wide-scale deployment of the Internet of Things and 5G technology. Further information can be found at www.st.com.

About Arrival

Arrival (NASDAQ: ARVL) is reinventing the automotive industry with its entirely new approach to the design and assembly of electric vehicles. Low CapEx, rapidly scalable Microfactories combined with proprietary in-house developed components, materials and software, enable the production of best in class vehicles competitively priced to fossil fuel variants and with a substantially lower total cost of ownership. This transformative approach provides cities globally with the solutions they need to create sustainable urban environments and exceptional experiences for their citizens. Arrival is a global business founded in 2015 and headquartered in London, UK and Charlotte, North Carolina, USA, with more than 1,900 global employees located in offices across the United States, Germany, the Netherlands, Israel, Russia, and Luxembourg. The company is deploying its first four microfactories in North Carolina, USA, South Carolina, USA, Bicester, UK and Madrid, Spain.

Forward Looking Statements

This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the products offered by Arrival and the markets in which it operates, Arrival’s ability to produce electric commercial vehicles, expectations regarding the benefits of the collaboration between Arrival and ST and expectations regarding the benefits of Arrival’s Microfactories. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation of information currently available. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including, but not limited to: (i) the impact of COVID-19 on Arrival’s business; (ii) the risk of downturns and the possibility of rapid change in the highly competitive industry in which Arrival operates, (iii) the risk that Arrival and its current and future collaborators are unable to successfully develop and commercialize Arrival’s products or services, or experience significant delays in doing so, (iv) the risk that Arrival may never achieve or sustain profitability; (v) the risk that Arrival experiences difficulties in managing its growth and expanding operations, (vi) the risk that third-parties suppliers and manufacturers are not able to fully and timely meet their obligations; (vii) the risk that the utilization of Microfactories will not provide the expected benefits due to, among other things, the inability to locate appropriate buildings to use as Microfactories, Microfactories needing a larger than anticipated factory footprint, and the inability of Arrival to deploy Microfactories in the anticipated time frame; (viii) the risk that the orders that have been placed for vehicles, including the order from UPS, are cancelled or modified; (ix) the risk of product liability or regulatory lawsuits or proceedings relating to Arrival’s products and services; and (x) the risk that Arrival will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; and (xi) the risk that Arrival is unable to secure or protect its intellectual property. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Arrival’s annual report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on April 30, 2021 and other documents filed by Arrival with the SEC from time to time. Readers are cautioned not to put undue reliance on forward-looking statements, and Arrival assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Arrival does not give any assurance that Arrival will achieve its expectations.

For Press Information Contact:

Michael Markowitz
Director Technical Media Relations
STMicroelectronics
Tel: +1 781 591 0354
Email: [email protected]

Rachael Charlton
Head of PR
Arrival
Email: [email protected]

Attachments

• T4372A — Jun 24 2021 — ST_Arrival EV collaboration_FINAL FOR PUBLICATION
• ST-Arrival Joint PR image_2

HOUSTON, June 24, 2021 (GLOBE NEWSWIRE) — Aravive Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing innovative therapeutics to treat life-threatening diseases, today announced positive initial results from the Phase 1b portion of its Phase 1b/2 study in patients dosed with 15mg/kg of AVB-500 in combination with cabozantinib who have clear cell renal cell carcinoma (advanced stage kidney cancer). The data in three evaluable patients showed that AVB-500 was well tolerated with no unexpected findings.

Based on the pharmacokinetics, pharmacodynamics, and safety data at 15mg/kg of AVB-500, and approval by the Data and Safety Monitoring Board (DSMB), the Company plans to expand the dosing of 15mg/kg of AVB-500 to an additional three patients to determine the potential of initiating the Phase 2 portion with this dose. The Company also expects to continue to investigate higher doses of AVB-500 in the Phase 1b to obtain additional safety, pharmacokinetics, and pharmacodynamics information.

“We are pleased to announce the favorable results in the first cohort of our clear cell renal cell carcinoma Phase 1b study, as we continue to advance AVB-500 and evaluate its ability to address an urgent, high unmet medical need in patients with advanced kidney cancer who have very low survival rates,” said Gail McIntyre, Ph.D., Chief Executive Officer of Aravive. “We continue to focus on difficult-to-treat life threatening cancers with AVB-500, and in addition to our clear cell renal cell carcinoma clinical trial, our lead indication in paclitaxel resistant ovarian cancer is in a Phase 3 clinical trial, and we recently announced that we plan to initiate a Phase 1b/2 clinical trial in first-line metastatic pancreatic cancer in the second half of this year. We are enthusiastic about the clinical data with AVB-500 in combination with anticancer therapies that continue to show consistent PK/PD data and a favorable safety profile. These combinations may have the potential to be used in a range of different cancers.”

About the AVB-500 Phase 1b/2 Clinical Trial in Clear Cell Renal Cell Carcinoma (ccRCC)

Aravive initiated its Phase1b portion of the Phase 1b/2 trial of AVB-500 in ccRCC in March 2021.   The Phase 1b portion of the clinical trial, a dose escalation study, is expected to enroll up to a total of 18 patients in three dosing arms (15 mg/kg, 20 mg/kg and 25 mg/kg) to evaluate tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of AVB-500 in combination with cabozantinib. The controlled, randomized, open-label Phase 2 portion of the clinical trial is expected to enroll up to 45 patients and investigate the recommended AVB-500 dose identified during the Phase 1b portion of the clinical trial in combination with cabozantinib versus cabozantinib alone. The primary endpoint is progression-free survival. The trial will enroll patients with advanced clear cell renal cell carcinoma (ccRCC) who have progressed on front-line treatment. The Phase 1b/2 trial is listed on clinicaltrials.gov NCT04300140.

About AVB-500

AVB-500 is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity in preclinical models. In doing so, AVB-500 selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian cancer. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity in combination with a variety of anticancer therapies, including radiation therapy, immuno-oncology agents, and chemotherapeutic drugs that affect DNA replication and repair. Increased expression of AXL and GAS6 in tumors has been correlated with poor prognosis and decreased survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies. AVB-500 is currently being evaluated in clinical trials and has been granted Fast Track Designation by the U.S. Food and Drug Administration in platinum resistant recurrent ovarian cancer. Analysis of all safety data to date showed that AVB-500 has been generally well-tolerated with no dose-limiting toxicities or unexpected safety signals.

About Aravive

Aravive, Inc. is a clinical-stage oncology company developing innovative therapeutics designed to halt the progression of life-threatening diseases. Aravive is based in Houston, Texas and received a Product Development Award from the Cancer Prevention & Research Institute of Texas (CPRIT) in 2016. Aravive’s lead therapeutic, AVB-500, is an ultra-high affinity decoy protein that targets the GAS6-AXL signaling pathway associated with tumor cell growth. Aravive successfully completed a Phase 1b trial of AVB-500 in platinum resistant ovarian cancer and has initiated a registrational Phase 3 trial of AVB-500 at a dose of 15 mg/kg. While the Phase 1b trial of AVB-500 in platinum resistant ovarian cancer was a safety trial and not powered to demonstrate efficacy, all 5 patients in the 15 mg/kg cohort experienced clinical benefit, with 1 complete response, 2 partial responses, and 2 stable disease. The Company is dosing patients in its Phase 1b/2 trial in clear cell renal cell carcinoma. For more information, please visit www.aravive.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions and includes statements regarding plans to expand the dosing of 15mg/kg of AVB-500 to an additional three patients to determine the potential of initiating the Phase 2 portion with this dose, investigating higher doses of AVB-500 in the Phase 1b to obtain additional safety, pharmacokinetics, and pharmacodynamics information, plans to initiate a Phase 1b/2 clinical trial in first-line metastatic pancreatic cancer in the second half of this year and the expected enrollment of the Phase 1b and Phase 2 portion of the trial of AVB-500 in ccRCC . Forward-looking statements are based on current beliefs and assumptions, are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those contained in any forward-looking statement as a result of various factors, including, but not limited to, risks and uncertainties related to: the Company’s ability to recruit for and enroll the expected number of patients into the Phase 1b and Phase 2 3 trial of AVB-500 in ccRCC as planned and continue dosing as planned the impact of COVID-19 on the Company’s clinical strategy, clinical trials, supply chain and fundraising, the Company’s ability to expand development into additional oncology indications, the Company’s dependence upon AVB-500, AVB-500’s ability to have favorable results in clinical trials and ISTs, the clinical trials of AVB-500 having results that are as favorable as those of preclinical and clinical trials, the ability to receive regulatory approval, potential delays in the Company’s clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients especially in light of the COVID-19 pandemic; the risk that AVB-500 may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that the Company may encounter difficulties in manufacturing AVB-500; if AVB-500 is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing the Company’s intellectual property rights; the Company’s reliance on its licensor of intellectual property and financing needs. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, recent Current Reports on Form 8-K and subsequent filings with the SEC. Except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

Joseph T. Schepers
VP, Investor Relations, Aravive, Inc.
[email protected]
(770) 558-5517

GREENWICH, Conn., June 24, 2021 (GLOBE NEWSWIRE) —  XPO Logistics, Inc. (NYSE: XPO), a leading global provider of supply chain solutions, will take to the road on June 26 as the official transport partner of the Tour de France for the 41st consecutive year. When the Tour winner is declared in Paris on July 18, a team of 75 XPO drivers will have piloted 54 trucks over 3,383 kilometers, moving more than 420 tons of cargo.

XPO is responsible for ensuring the time-critical transport of equipment, fixtures, safety barriers and supplies throughout the Tour’s 21 stages for organizer Amaury Sport Organisation (A.S.O). The partners share a strong commitment to the safety and sustainability of race operations. XPO drivers and support staff will receive COVID-19 safety training and protective supplies, replicating the rigorous safety protocols that XPO and A.S.O. initiated together in 2020.

In addition, XPO has expanded its eco-friendly approach to this year’s event. The company will trial the biofuel Oleo100 in one of its Euro 6 diesel trucks for the first time, and will use a natural gas-powered truck from its alternative-fuel fleet for the final arrival at the Champs-Élysées finish line. All other trucks deployed by XPO for will use Euro 6 clean diesel engines, and the company is providing eco-training and organically sourced uniforms for its drivers.

Luis Gomez, managing director, transport – Europe, XPO Logistics, said, “The Tour de France is a thrilling challenge for our team, and we’re proud to once again serve as the competition’s official transport partner. We’ll be providing A.S.O. with a record level of support this year, while contributing to a greener profile of Tour operations.”

Jean-Luc Duplantier, logistics director of A.S.O., said, “XPO has risen to the challenge for many years, while constantly seeking to enhance their services. As we bring the Tour de France to over 10 million fans worldwide in 2021, XPO’s vital role behind the scenes will help ensure success.”

XPO will also participate in the Tour Fan Parks for the first time this year, offering blind spot awareness workshops and highlighting employment opportunities. Race followers can meet the XPO team at the free-admission Fan Park venues at Laval on June 29 and 30, Albertville on July 5 and 6, and Libourne on July 16 and 17.

XPO has a long track record of serving as an official partner for world-class sporting events, including the Ironman Triathlons in Europe, Schneider Electric Paris Marathon, Tour Voile (sailing), Evian Championship (golf), Arctic Race of Norway (cycling), Freeride World Tour (skiing and snowboarding), Coupe de France (soccer) and other premier competitions.

About XPO Logistics

XPO Logistics, Inc. (NYSE: XPO) provides cutting-edge supply chain solutions to the most successful companies in the world, with two business segments: transportation and logistics. The company helps more than 50,000 customers manage their supply chains most efficiently, using a network of 1,621 locations in 30 countries and approximately 140,000 team members, including 108,000 employees and 32,000 temporary workers. The company’s corporate headquarters are in Greenwich, Conn. USA. Visit xpo.com for more information, and connect with XPO on Facebook, Twitter, LinkedIn, Instagram and YouTube. 

Media Contacts 
XPO Logistics, Inc. 
Joe Checkler 
+1-203-423-2098 
[email protected] 

XPO Logistics Europe 
Anne Lafourcade 
[email protected] 
+33 (0)6 75 22 52 90 

– Activities to support the next stage of clinical development of ACHM B3 candidate are ongoing-

– Dosing of pediatric patients in ACHM B3 program and ACHM A3 program is expected to be completed in August 2021 –

– Conference call to review data today at 8:00am ET –

GAINESVILLE, Fla. and CAMBRIDGE, Mass., June 24, 2021 (GLOBE NEWSWIRE) — Applied Genetic Technologies Corporation (Nasdaq: AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare retinal diseases, today reported 12-month data from its ongoing achromatopsia (ACHM) Phase 1/2 clinical trials, including data from all adult patients and low-dose pediatric patients. For its ACHM B3 candidate, results demonstrate biologic activity based on improvements in visual sensitivity in the treated area measured by static perimetry and light discomfort measured by the Ocular Photosensitivity Analyzer (OPA) and are supported by anecdotal patient reports. In addition, the safety profile of the Company’s ophthalmic gene therapy platform remained favorable. Based on these data, AGTC intends to advance the ACHM B3 trial to the next stage of clinical development. The path forward for ACHM A3 will be determined after additional pediatric patient data and pre-clinical studies are available and can be evaluated.

“The results regarding responders in the ACHM B3 trial are encouraging,” said Rachel Huckfeldt, MD, PhD, Assistant Professor of Ophthalmology at Harvard Medical School and an investigator on the ongoing AGTC achromatopsia Phase 1/2 trials. “The data from the ACHM B3 trial support further clinical investigation of this candidate, and data from additional pediatric patients may support the focused development of the ACHM A3 candidate specifically in younger patients.” 

“We are incredibly pleased with these data, which further support AGTC as a leader in the field of ophthalmic gene therapy. Our strong capabilities lead to differentiated products based on capsid and vector engineering, robust manufacturing, and rigorous preclinical evaluation of our product candidates in validated models of retinal diseases,” said Sue Washer, President and CEO of AGTC. “We believe that these data provide important validation for the broad potential of our AAV technology platform and build on and extend the favorable safety and efficacy profiles observed to date in the clinical trials of our candidate for X-linked retinitis pigmentosa.”

ACHM B3 12-Month Results

12-month data, which are available for 25 patients, consisting of 21 adult and 4 pediatric (<18 years of age) patients, show continued improvements on perimetry for higher dose and younger patients and include positive patient anecdotes. Improvements in retinal sensitivity as measured by static perimetry were seen in the treated eye compared with the untreated eye in four of 11 patients from the high-dose and pediatric cohorts. Improvements in light discomfort as measured by OPA, were also observed in six of these 11 patients.

Improvements in light discomfort also were observed in the untreated eye of these patients, which we believe may suggest possible cortical adaptation within the brain. There is no evidence that this observation is due to the presence of the ACHM B3 vector in the untreated eye. At the Company’s R&D Day, which is scheduled to take place on Thursday, July 22, 2021, beginning at 10:00 AM ET, an external expert is scheduled to provide a more detailed analysis of the bilateral light discomfort finding and its potential causes. This will be in addition to clinical investigators presenting a detailed patient by patient review of all the data to date.

Based on these data, AGTC plans to advance its ACHM B3 program to the next stage of clinical development. Toward this end, the Company is drafting an End-of-Phase 2 (EOP2) briefing packet to submit to the U.S. Food and Drug Administration, developing assays for pivotal ready testing, and planning production of clinical trial material.

AGTC plans to continue to collect data from younger pediatric patients that may provide additional supportive data for the development of ACHM B3, but this data will not be a gating factor for the Company’s current clinical development activities.

ACHM A3 12-Month Results

12-month data are available for 20 patients, including 16 adults and 4 pediatric patients. The results at this time point do not show consistent evidence of ACHM A3 candidate biologic activity, although we believe that the patient-reported anecdotes continue to be encouraging. In contrast with patients in the B3 trial, the majority of whom have mutations that results in the complete absence of B3 protein, the majority of A3 patients have mutations that result in the production of non-functional protein. The results observed to date in the Phase 1/2 ACHM trials suggest that the presence of these non-functional proteins may interfere with the activity of the vector expressed ACHM A3 protein. There will be an external expert at R&D Day to provide a deeper analysis.

Safety Data

Consistent with earlier data from the Company’s ACHM Phase 1/2 trials and data out to 24 months for its X-linked retinitis pigmentosa candidate, 12-month ACHM data continue to support a favorable safety profile for AGTC’s AAV technology platform. No serious adverse events (SAEs) related to the ACHM candidates were reported; one SAE was related to the surgical procedure and has resolved, two SAEs were related to the use of steroids and one has resolved, and one is improving.

Upcoming ACHM Clinical Milestones

AGTC believes it has a best-in-class ACHM B3 product candidate that may provide significant benefit to patients. The Company expects to report 3-month data from younger pediatric patients in both the ACHM B3 and ACHM A3 trials in the fourth quarter of 2021.

Conference Call and Webcast

AGTC will host a conference call and webcast to discuss the 12-month data from its ongoing Phase 1/2 ACHM clinical trials today at 8:00am ET. The live webcast will be available in the Events and Presentations section of the Investor Relations page at http://ir.agtc.com/events-and-presentations. To access the call, dial 877-407-6184 (US) or 201-389-0877 (outside of the US). Please log in approximately 10 minutes prior to the scheduled start time.

The archived webcast will be available in the Events and Presentations section of the Company’s website.

About AGTC

AGTC is a clinical-stage biotechnology company developing genetic therapies for people with rare and debilitating ophthalmic, otologic and central nervous system (CNS) diseases. AGTC is a leader in designing and constructing all critical gene therapy elements and bringing them together to develop customized therapies that address real patient needs. AGTC’s most advanced clinical programs leverage its best-in-class technology platform to potentially improve vision for patients with an inherited retinal disease. AGTC has active clinical trials in X-linked retinitis pigmentosa (XLRP) and achromatopsia (ACHM B3 and ACHM A3). Its preclinical programs build on the Company’s industry leading AAV manufacturing technology and scientific expertise. AGTC is advancing multiple important pipeline candidates to address substantial unmet clinical need in optogenetics, otology and CNS disorders. In recent years AGTC has entered into strategic partnerships with companies including Otonomy, Inc., a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, and Bionic Sight, LLC, an innovator in the emerging field of optogenetics and retinal coding.

Forward-Looking Statements

This release contains forward-looking statements that reflect AGTC’s plans, estimates, assumptions and beliefs, including statements regarding AGTC’s proposed clinical development of ACHM B3, planned pediatric surgeries for its ACHM clinical programs and the potential that future pediatric data will be supportive of future development of ACHM A3, the potential results of both its ACHM trials, its ability to enroll patients for its clinical trials, regulatory progress, potential growth and market opportunities, and the effects of competition. Forward-looking statements include information concerning possible or assumed future results of operations, financial guidance, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities, the effects of competition and the impact of the COVID-19 pandemic, including the impact on its ability to enroll patients. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: gene therapy is still novel with only a few approved treatments so far; AGTC cannot predict when or if it will obtain regulatory approval to commercialize a product candidate or receive reasonable reimbursement; uncertainty inherent in clinical trials and the regulatory review process; risks and uncertainties associated with drug development and commercialization; the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations, and financial condition; factors that could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading “Risk Factors” in our most recent annual or quarterly report and in other reports we have filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management’s plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

IR/PR CONTACTS: 

David Carey (IR) or Glenn Silver (PR)
Lazar FINN Partners
T: 212-867-1768 or 646-871-8485
[email protected] or [email protected]

Corporate Contact:

Stephen Potter
Chief Business Officer
Applied Genetic Technologies Corporation
T: 617-413-2754
[email protected]

CAMBRIDGE, Mass., June 24, 2021 (GLOBE NEWSWIRE) — Werewolf Therapeutics, Inc., an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, today announced that it will be added to the Russell 2000® Index at the conclusion of the Russell US Indexes annual reconstitution on June 28, 2021.

“Werewolf’s inclusion in the Russell 2000® index marks an important milestone that reflects the continued progress we are making toward advancing our lead therapeutic programs, WTX-124 and WTX-330, into the clinic,” said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf Therapeutics. “We are pleased to join the Russell Index and look forward to sharing our story with a broader audience of investors.”

The Russell 2000® Index measures the performance of the small-cap segment of the U.S. equity market. The index is a subset of the Russell 3000® Index and represents approximately 10 percent of the total market capitalization of that index. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

For more information on the Russell 2000® Index and the Russell indexes reconstitution, visit the FTSE Russell website.

About Werewolf Therapeutics, Inc.

Werewolf Therapeutics, Inc. is an innovative biopharmaceutical company pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of cancer. We are leveraging our proprietary PREDATOR™ platform to design conditionally activated molecules that stimulate both adaptive and innate immunity with the goal of addressing the limitations of conventional proinflammatory immune therapies. Our INDUKINE™ molecules are intended to remain inactive in peripheral tissue yet activate selectively in the tumor microenvironment. Our most advanced product candidates, WTX-124 and WTX-330, are systemically delivered, conditionally activated Interleukin-2 (IL-2) and Interleukin-12 (IL-12) INDUKINE molecules, respectively, for the treatment of solid tumors. We are continuing preclinical studies for both WTX-124 and WTX-330 and expect to advance each candidate in multiple tumor types as a single agent and in combination with an immune checkpoint inhibitor.

To learn more visit www.werewolftx.com.

Investor Contact:

Alan Lada
Solebury Trout
617.221.8006
[email protected]   

Media Contact:

Amanda Sellers
VERGE Scientific Communications
301.332.5574
[email protected]    

Company Contact:

Ellen Lubman
Chief Business Officer
Werewolf Therapeutics
[email protected]